The efficacy of add-on tacrolimus for minor flare in patients with systemic lupus erythematosus: a retrospective study

Lupus. 2016 Jan;25(1):54-60. doi: 10.1177/0961203315600538. Epub 2015 Aug 21.


Objective: We have assessed the effectiveness of tacrolimus for minor flares in systemic lupus erythematosus (SLE) patients.

Methods: The medical records of 313 patients were retrospectively reviewed over a period of seven years, from 2006 to 2013. We enrolled patients with minor flare treated with add-on tacrolimus, without glucocorticoid (GC) intensification (tacrolimus group). Minor flare was defined as a ≥ 1-point increase in a total score between 3 and 11 in the SLE Disease Activity Index (SLEDAI). We enrolled as controls patients who were administered increased doses of GC for minor flare (GC group). All patients were followed for one year. The primary outcome measure was the proportion of responders.

Results: There were 14 eligible patients in the tacrolimus group and 20 eligible patients in the GC group. The mean SLEDAI at flare tended to be higher in the tacrolimus group than in the GC group (7.5 vs. 6.2, p = 0.085). A mean dose of 1.6 mg tacrolimus/day was administered for flare, while the mean GC dose was 13.7 mg/day in the GC group. The proportion of responders was 86% (12/14) in the tacrolimus group and 75% (15/20) in the GC group (p = 0.67). The mean dose of GC at 12 months was higher in the GC group than in the tacrolimus group (9.7 mg/day vs. 7.1 mg/day, p < 0.05). Only one patient discontinued tacrolimus because of fatigue after three months.

Conclusion: Adding tacrolimus without increasing the GC dose may provide an effective treatment option for minor flares in patients with SLE.

Keywords: Tacrolimus; minor flare; systemic lupus erythematosus.

MeSH terms

  • Adult
  • Disease Progression
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / administration & dosage
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Lupus Erythematosus, Systemic / diagnosis
  • Lupus Erythematosus, Systemic / drug therapy*
  • Male
  • Medical Records
  • Middle Aged
  • Retrospective Studies
  • Severity of Illness Index
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Time Factors
  • Treatment Outcome


  • Glucocorticoids
  • Immunosuppressive Agents
  • Tacrolimus